Enhanced Recovery in Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Acute Cholecystitis; Gangrenous Cholecystitis
• Interventions: Procedure: Laparoscopic cholecystectomy with the implementation of modified ERAS program; Procedure: Laparoscopic cholecystectomy with standard perioperative treatment

• Registration Number: NCT03754751
• Lead Sponsor: Pirogov Russian National Research Medical University

Brief Summary

The study assesses the impact of the modified enhanced recovery protocol on the results of surgical treatment of patients with acute cholecystitis.

Detailed Description

Laparoscopic cholecystectomy (LC) is the most common surgical procedures in the world. Elective LC is commonly performed as one-day surgery, while in an emergency setting of acute cholecystitis the in-hospital stay averages 4.5 days. Causes of prolonged rehabilitation period are often associated with severe pain syndrome, dyspepsia and postoperative complications. The complications rate after LC is about 6% and has no tendency to decrease. The implementation of enhanced recovery after surgery (ERAS) programs may potentially reduce stress-associated complications and improve the quality of rehabilitation. A few retrospective studies examined their advantages and setbacks in the treatment of acute cholecystitis with encouraging results. The aim of this randomized control study is to evaluate the modified ERAS program for patients with acute cholecystitis.

Study Timeline

• Study Start: 2017-01-31
• Study First Submitted: 2018-11-21
• Study First Submitted QC: 2018-11-26
• Study First Posted: 2018-11-27
• Primary Completion: 2019-01-01
• Study Completion: 2019-01-30
• Status Verified: 2019-11
• Last Update Submitted: 2021-01-14
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 189

Inclusion Criteria

• Grade I and II acute cholecystitis according to Tokyo Guidelines 2013 classification (TG13)
• ASA I and II.

Exclusion Criteria

• Severe acute cholecystitis (Grade III on TG13);
• Patient's refusal to participate;
• The language barrier;
• Transfer to the intensive care unit after surgery;
• ASA class ≥ III;
• Conversion to open procedure;
• Biliary hypertension detected during preoperative examination or intraoperatively.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified ERAS program group	Laparoscopic cholecystectomy with the implementation of modified ERAS program	Laparoscopic cholecystectomy with the implementation of modified ERAS program
Conventional care group	Laparoscopic cholecystectomy with standard perioperative treatment	Laparoscopic cholecystectomy with standard perioperative treatment

Primary Outcome Measures

Name	Time	Method
Postoperative length of stay (pLOS)	30 days	Time interval measured from the end of the surgery until the moment of discharge from the hospital, measured in days

Secondary Outcome Measures

Name	Time	Method
Readmission rate	30 days	Number of patients with readmission to the hospital after discharge in relation to the total number of patients, measured as a percentage
Shoulder pain incidence	24 hours	Quantity of patients who developed shoulder pain after surgery in relation to the total number of patients, measured as a percentage
Complication rate	30 days	Number of patients who develop postoperative complications (surgical site infections, intraabdominal organ-specific infection, postoperative ileus) in relation to the total number of patients, measured in percentage
Postoperative pain	24 hours	Level of postoperative pain syndrome measured with a visual analog scale in centimeters
Shoulder pain level	24 hours	Level of shoulder pain syndrome measured with a visual analog scale in centimeters

Trial Locations

Locations (1)

Taras Nechay; 🇷🇺 Moscow, Russian Federation